Catalog Number

12251

Brand Name

AVANOS*

Version/Model Number

12251

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Public Device Record Key

0aa03099-5492-40ea-acff-59e951e3c214

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 19, 2020

Package DI Number

10609038968787

Quantity per Package

20

Contains DI Package

00609038968780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP